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julienneviuya replied to the topic DHF vs. DHR in the forum Device Documentation 7 years, 2 months ago
There is a vast difference between the Design History File (DHF) and the Device History Record (DHR). Once the timeline during which these are created is understood, the difference is apparent. The Design History File is created during the product development stage of the device. This is the main deliverable of the Design Input phase containing the records involved in the design of the device. There is one DHF for the device project as a whole, and this is written before the manufacturing process of the device even begins. This is different from the DHR because the DHR is one per individual device manufactured. This details all of the processes that occur when that device was made, down to the operator responsible for each stage in production. This follows the individual device through the entire process and is later filed away but is still accessible to see how that individual device was made.